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Drug Regulation and Control Drug Regulation and Control Chapter Outline • Drug Regulation! • Behind-the-counter Medications! • Sample Labels! • Controlled Substances! • Public Safety! • Law and the Technician Brief History of Statutory Pharmacy Law • In the 19th century, drugs in the United States were unregulated.! • Medicines did not require proof that they were either safe or effective.! • Most agents contained a high content of alcohol.! • Some caused injury or death. Pharmacy Law - 1906 • To combat abuses in both formulation and labeling, in 1906 the U.S. Congress passed the first of a series of landmark 20th century laws to regulate drugs. Pure Food and Drug Act of 1906 • The purpose was to prohibit the sale of adulterated or misbranded food and drugs.! • Adulterated is impure by adding extraneous, improper, or inferior ingredients.! • Misbranded to brand or label misleadingly or fraudulently.! • Labels could not contain false information about the drugs’ strength and purity. ! • Proved unenforceable and new legislation was required. Harrison Tax Act 1914 • Established that manufacturers, pharmacists, importer, and physicians prescribing narcotics should be Licensed and required to pay a tax.! • The law enacted in response to growing opiates and cocaine- containing medications. Food, Drug, and Cosmetic (FDC) Act of 1938 • Sulfa poisoning caused the death of 107 people, primarily children.! • Due to untested sulfanilamide concoction.! • In response to this event, FDC was introduced. ! • FDC is the most important piece of legislation in pharmaceutical history.! • Required only that drugs be SAFE for human consumption before marketing. FDC Act of 1938 • Gave FDA the power to conduct inspections of manufacturing plants to ensure compliance.! • Act applied to interstate transactions, as well as to intrastate transactions.! • FDA required pharmaceutical manufacturers to file a new drug application (NDA) with each new drug before marketing. Durham-Humphrey Amendment of 1951 • States that drug containers do not have to include “adequate directions for use” as long as they include! • “Caution: Federal Law Prohibits Dispensing Without Prescription.” ! • Now, “Rx Only.”! • Distinguished between! • Legend (prescription) drugs.! • Over-the-counter (OTC) (non-prescription) drugs.! • Authorized! • Verbal prescriptions. ! • Prescription refills. Kefauver-Harris Amendment of 1962 • Extended the FDC Act of 1938 to require that! • Drugs not only be safe for humans but also be EFFECTIVE. Kefauver-Harris Amendment of 1962 • Requirement of drug manufacturers:! • An investigational new drug application (INDA) with the FDA before initiating a clinical trial in humans.! • Once proven safe and effective, manufacturer may submit an NDA seeking approval to market the product. Poison Prevention Packaging Act of 1970 • Passed to prevent accidental childhood poisonings from prescription and nonprescription products. ! • Enforced by the Consumer Product Safety Commission (CPSC). Poison Prevention Packaging Act of 1970 • Requires most over-the-counter (OTC) and prescription drugs to be packaged in child- resistant containers.! • Cannot be opened by 80% of children under five. ! • Can be opened by 90% of adults. ! • Patients may request a non-child-resistant container; other exceptions are provided for by law. Comprehensive Drug Abuse Prevention and Control Act of 1970 • Commonly referred to as the Controlled Substances Act (CSA).! • Created to combat and control drug abuse and to supersede previous federal drug abuse laws.! • Created the Drug Enforcement Administration (DEA), an arm of the Department of Justice. ! • Charged with enforcement and prevention related to the abuse of controlled substances like many narcotic pain medications. CSA – 1970 • Classified drugs with potential for abuse as controlled substances.! • Ranked controlled substances into five categories, or schedules.! • Ranging from those with great potential for abuse (Schedule I) to those with little potential (Schedule V). CSA - 1970 Schedule Medical Use Examples I For research only – not Heroin, LSD approved for human use II Dispensing severely Morphine, oxycodone, restricted amphetamines III Prescriptions can be refilled Codeine with aspirin, up to 5 times in 6 months anabolic steroids IV Same as for Schedule III Benzodiazepines, meprobamate V Some sold w/o a Liquid codeine prescription; must be 18 combination preps. Drug Listing Act of 1972 • Gives the FDA the authority to compile a list of currently marketed drugs. ! • Each drug is assigned a unique and permanent product code ! – Known as a National Drug Code (NDC).! – Eleven characters that identify manufacturer or distributor, drug formulation, size and type of packaging.! • FDA requests, but does not require, that the NDC appear on all drug labels. National Drug Code (NDC Number) • Identification number assigned by the manufacturer to a drug product.! • Has 3 sets of numbers.! ! !!!1st five digits! 60951-0602-85 3rd two digits! manufacturer package size 2nd four digits! strength and form 1976 Medical Device Amendment • The Medical Device Amendment requires pre-market approval of safety and effectiveness of life sustaining and life supporting medical devices. Orphan Drug Act of 1983" • An orphan drug is intended for use in a few patients with a rare disease or condition. ! • Developing such a drug would be prohibitively expensive, given the small market.! • The Orphan Drug Act encourages the development of orphan drugs by: ! • Providing tax incentives. ! • Granting manufacturers exclusive license.! • Over 250 orphan drugs have been approved by the FDA. Drug Price Competition and Patent-Term Restoration Act of 1984 • Also called Hatch-Waxman Act.! • Allows substitution of brand name products with generic drugs. ! • Once the original patent expires, any manufacturer may market a generic drug.! • FDA approval is required to market a generic ! • Generic is less costly than the brand name. Drug Price Competition and Patient-Term Restoration Act of 1984 • A given drug typically has several names.! • Generic name is a common name given to a drug regardless of brand name.! • One or more brand names under which the manufacturer markets a drug.! • Example! • Ro 18-0647!!!Research #! • Tetrahydrolipstatin!!Non-official generic! • Orlistat! !!!Approved Generic! • Xenical!! !!Trade Name (Brand)! • Alli!!!!Trade Name (OTC) Prescription Drug Marketing Act of 1987 • PROHIBITS ! • Re-importation of a drug into the United States.! • PROHIBITS! • Sale or trading of drug samples.! • PROHIBITS ! • Distribution of samples to persons other than those licensed to prescribe them except by mail or by common carrier. OBRA-90 • Omnibus Budget Reconciliation Act of 1990 ! • Requires states to establish standards for Drug Use Review (DUR) by the pharmacist.! • Requires pharmacists to offer counseling to Medicaid patients.! • 45 states implemented counseling for all patients.! • Requires a manufacturers rebate to state Medicaid program between the manufacturer’s best price for a drug (typically the wholesale price) and the average billed price. HIPAA of 1996 Health Insurance Portability and Accountability Act! • Defines the scope of health information that may or may not be shared among health care providers without patient consent. FDA Modernization Act • Authorizes fees to be added to a new drug application (NDA) process to accelerate the review and approval process for new drugs.! • Updates the labeling on prescription medications ! • Products labeled are “Rx Only.” ! • New labeling requirements were implemented in 2004. The FDA’s Center for Drug Evaluation & Research (CDER) • Provides an Index to Drug-Specific Information with patient, consumer and healthcare professional information sheets, including FDA Alerts. ! • Works with drug manufacturers to develop risk management programs for drugs with FDA. ! – Alerts, such as the iPLEDGE program for Accutane. New Drug Approval Process • All new drugs require FDA approval before they can be marketed in the US.! • To receive approval, new drugs must be shown to be SAFE and EFFECTIVE and its benefits OUTWEIGH its risks.! • Drug manufacturers and not the FDA is responsible for proof.! • This process will be the subject of our next class. Look Alike and Sound Alike Drugs • Federal laws require containers NOT to look like another drug, however some drug names may look alike or sound alike.! • Example:! – Kapidex: used to treat heartburn/reflux! !!Confused with:! – Casodex (sound alike) Prostate cancer! – Kadian (look alike) Morphine for pain Over-the-Counter (OTC) Drugs • OTC drugs must be approved by the FDA .! ! • Can be used upon the judgment of the consumer without a prescription from a physician.! ! • Generally, OTC drugs are intended for short term use. Over-the-Counter (OTC) Drugs • There are over 100,000 OTC drugs in 80 therapeutic categories.! • The manufacturer has to follow a format called drug monograph to be able to market with proper label including:! • Active ingredient!!! • Direction for use! • Amount of drug contained! • Warnings!!!! • Expiration date Sample OTC Label Behind-The-Counter OTC Medications • Medications sold without a prescription, but with RESTRICTION on their sales.! • Kept behind the pharmacy counter.! • Examples! • Pseudoephedrine! • Some Codeine containing cough preparations Exempt Narcotics • Sold by a pharmacist without a prescription.! • E.g. Codeine containing cough syrups.! • Only pharmacists can approve their dispensing. Exempt Narcotics • Purchasers have to:! • Be at least 18 years old.! • Provide
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